Kornimate/medical-research-clean huggingface dataset:
olverembatinib plus venetoclax and dexamethasone for treatment-naïve ph+ acute lymphoblastic leukemia

Conditions: Newly-diagnosed Ph+ Acute Lymphoblastic Leukemia

Summary: the purpose of this study is to explore the efficacy and safety of the ovd chemotherapy-free regimen (olverembatinib, venetoclax and dexamethasone) in patients with newly-diagnosed ph+all.

primary objectives: to determine the complete remission (cr) and complete remission with incomplete hematologic recovery (cri) rates, the measurable residual disease (mrd) rates, the complete molecular remissions (cmr) rates and the progression-free survival (pfs) of the ovd chemotherapy-free regimen (olverembatinib, venetoclax and dexamethasone) in patients with newly-diagnosed ph+all. secondary objectives: to describe the toxicities of the ovd regimen. to assess the quality of life and overall survival of the ovd chemotherapy-free regimen in patients with newly-diagnosed ph+all.

Eligibility criteria:
inclusion criteria: * diagnosis of newly-diagnosed ph+ acute lymphoblastic leukemia * age \>= 18 * adequate hepatic function * adequate renal function * adequate heart function * life expectancy of more than 3 months * women of child-bearing potential and men with partners of child-bearing potential must agree to use 2 methods of birth control or be surgically sterile or abstain from heterosexual activity from the time of signing the informed consent for through 120 days after the last dose of study medication. * women of childbearing potential have negative pregnancy test within 72 hours of initiating study drug dosing. * male subjects must agree to use a latex condom during sexual contact with females of childbearing potential even if they have had a successful vasectomy starting with the first dose of study therapy through 120 days after the last dose of study therapy. * all subjects must be counseled at a minimum of every 28 days about pregnancy precautions and risks of fetal exposure. * females of reproductive potential must adhere to the scheduled pregnancy testing as required in the pomalyst rems program. exclusion criteria: * current or anticipated use of other investigational agents. * female patients who are lactating or have a positive serum pregnancy test during the screening period. * major surgery within 3 weeks prior to first dose * acute active infection requiring systemic antibiotics, antivirals, or antifungals within two weeks prior to first dose * known or suspected hiv infection, known hiv seropositivity * active hepatitis infection * has known chronic obstructive pulmonary disease with a forced expiratory volume in 1 second (fev1) \<50% of predicted normal * known gastrointestinal disease or procedure that could interfere with the oral absorption or tolerance, including difficulty swallowing
study to compare and assess the safety and pharmacokinetic characteristics after oral administration of fimasartan (br-a-657∙k) in healthy elderly and young male volunteers

Conditions: Essential Hypertension

Summary: the purpose of this study is to compare and assess the safety and pharmacokinetic characteristics after oral administration of fimasartan (br-a-657∙k) in healthy elderly and young male volunteers.

fimasartan (br-a-657-k), a selective blocker of at1 receptor subtype, showed the rapid and potent antihypertensive effect in many hypertensive models. phase i study, fimasartan (br-a-657-k) 20 mg \~ 480 mg single dosing with healthy subjects, demonstrated that the fimasartan (br-a-657-k) was very safe and well tolerated. another phase i study, fimasartan (br-a-657-k) 120mg and 360mg dosing for 7 days, also showed that fimasartan (br-a-657-k) was safe and tolerable though one temporal adverse event was observed in high dose. a open-labeled, single-dosing, parallel clinical study to evaluate pharmacokinetic characteristics after oral administration of fimasartan in healthy elderly and young male volunteers. 22 male healthy volunteers were enrolled during 2 months. in part a, 240 mg of fimasartan per day was taken once by younger male healthy volunteers in day 1. then blood and urine samples were collected 0, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 and 48 hours after administration. in part b, 240 mg of hydrochlorothiazide per day was taken once by elderly male healthy volunteers in day 1. then blood and urine samples were collected 0, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 and 48 hours after administration.

Eligibility criteria:
inclusion criteria: * age * young: 19-45 years * elderly: more than 65 years * sex: male * body weight: greater than 55 kg exclusion criteria: * patients with contraindication to angiotensin ii receptor antagonist. * patients with a history of liver, renal, gastrointestinal, hematological or cardiac diseases * patients with history or diseases which might affect absorption of the drug * patients with hiv, type b or c hepatitis * smokers of 20 or more cigarettes per day

Keywords: fimasartan healthy elderly and young male volunteer pharmacokinetic
improving capacity to reduce fall-related injury risk in older adults

Conditions: Fall Injury

Summary: fall arrest strategy training (fast) is a unique, simple exercise program designed to improve one's ability to prevent injury when a fall is unavoidable. women are more likely to participate in fall prevention programming than men despite risk of serious fall related injuries such as head injury similar in both men and women. the purpose of this project is to test differences between men and women's physical capacity to control the downward descent of a forward fall and prevent injury and to understand factors that influence participation of women and men in fall prevention programming. a total of 60 seniors (30 men and 30 women) age 60 years or older will do their regular activities for 12 weeks followed by 12 weeks of fast training. they will be tested before and after for muscle strength, balance and their ability to land and descend in a simulated forward fall using a safe protocol in our lab. group discussions among women and men after fast will help us determine facilitators and barriers to exercise participation.

the purpose of this proposed study is to advance our knowledge of this innovative and simple training program, fast, to determine if it has potential to improve the physical capacity to arrest a fall and reduce injury risk in older community-dwelling women and men. using our novel lab-based energy absorption and strength measures, we will be able to compare fall-arrest capacity changes in older men and women.this study will also help to inform strategies to engage older men in exercise programming. research goals and objectives: the principal research questions of this study are: 1. does the fast improve fall arrest capacity in older women and men as compared to usual activity (wait control period)?, 2. does fast increase arm muscle strength, response time, mobility and balance control compared to usual activity? , 3. are there sex differences in fall risk changes, fall arrest capacity, and chance of head impact? and 4. do men differ from women in their perceptions of the barriers and facilitators to participating in fast? the hypotheses are that: 1) fast will result in greater improvements in energy absorption, ue strength, response time and mobility compared to usual activity for both older men and women; however 2) men will demonstrate enhanced fall arrest capacity and 3) will identify unique barriers and facilitators to participation compared to women. the study is a quasi-experimental pre-post design with a wait list control period where 60 men and women, age 60 years or older will be recruited to participate in fast.

Eligibility criteria:
inclusion criteria: * adults aged 60 years living in the community exclusion criteria: * recent upper body injury or pain, * recent or history of more than one distal radial fracture, * history of upper extremity neurological conditions or conditions contradicting upper extremity strength testing or training, * signs of severe cognitive impairment identified with the mini-cog * unable to safely ambulate independently in the community
study to evaluate the long- term safety and efficacy of luspatercept in subjects who received at least one dose of luspatercept in the compassionate use phase

Conditions: Thalassemia Major

Summary: luspatercept represents the first and only erythroid maturation agent (ema) approved by the european commission (ec) and the food and drug administration (fda) capable of enhancing advanced erythrocyte maturation. the efficacy of luspatercept was demonstrated in the phase iii clinical trial called "believe." more than 200 italian patients with transfusion- dependent beta thalassemia aged ≥18 years who had no approved therapeutic alternatives to improve their clinical course were considered eligible for the 'compassionate' use program related to luspatercept and most of them received at least one dose of the drug before it was dispensed by the national health system (nhs), after approval by the pharmaceutical company and the ethics committee of the clinical center in which they were being followed.

one month after the publication in the official gazette of the italian republic of the aifa determination of price and reimbursement for the treatment indication covered by the program, those who were still on treatment and were, in clinical judgment, eligible to continue it, continued to receive the drug through dispensation by the nhs. because access to the compassionate phase was less restrictive than access to that in formal clinical trials and the patients included particularly representative of real life, collecting data on clinical characteristics at baseline, safety, and efficacy is critical to enriching the information available on this new therapy. continuing to collect efficacy, safety, and tolerability information beyond the compassionate phase is also essential for a more complete and accurate assessment, given the short duration of 'compassionate' treatment for a portion of the patients under study.

Eligibility criteria:
inclusion criteria: - subjects who received at least one dose of luspatercept in the compassionate phase exclusion criteria: - subjects who are not willing or able to sign the informed consent.
conservative physiotherapy and acromion morphology

Conditions: Subacromial Impingement Syndrome; Morphologic Change

Summary: in this study, we aimed to evaluate the short-term effects of conservative physiotherapy in the subacromial impingement syndrome (sis) and its relation to the acromion morphology.

the aim of this study is to investigate the short term effects of physiotherapy in sis patients on pain, range of motion, muscle strength, joint position sense and functionality and its relation to the acromion shape. fifty patients (26 female, 24 male) with sis were evaluated in this study. patiens were divided into 3 groups according to the their acromion morphology. a conservative physiotherapy method was applied to the patients. all patients were evaluated before and 4 weeks after the treatment.

Eligibility criteria:
inclusion criteria: * patients who were diagnosed (clinically and by mri) with sis by the physician, at a stage of ii-iii levels according to neer's criteria, who were undergoing physiotherapy for the first time and who had not received any treatment from the shoulder region before were included in this study. exclusion criteria: * patients who had a history of fracture in the upper extremity and, surgical operation from any part of the upper extremity, who had acute cervical disc herniation or a neuromuscular disease, receiving a medical therapy for pain relief, less than 80 % participation to sessions were excluded.

Keywords: physiotherapy acromion morphology subacromial impingement syndrome
study evaluating enbrel in patients with rheumatoid arthritis

Conditions: Rheumatoid Arthritis

Summary: the purpose of this study is to investigate the incidence of adverse events for patients with rheumatoid arthritis treated with enbrel under usual care settings. in addition, differences in injection site reactions based on whether health care professionals or patients administer enbrel will be assessed and evaluated.


Eligibility criteria:
inclusion criteria: * proven diagnosis of rheumatoid arthritis exclusion criteria: * contraindications according to summary of product characteristic (smpc)of enbrel® the following points will prevent or restrict participation: * patients who suffer from hypersensitivity to the active substance etanercept or to any of the excipients of enbrel® * treatment with enbrel® should not be initiated in patients with active infections including chronic or localized infections * patients with sepsis or risk of sepsis should not be treated

Keywords: rheumatoid arthritis
the effect of tai chi in treating fibromyalgia

Conditions: Fibromyalgia

Summary: to evaluate the effect of tai chi on fibromyalgia


Eligibility criteria:
inclusion criteria: * 40 years of age or older * meeting the classification of fm per the 1990 acr criteria * approval by a healthcare provider for participation exclusion criteria: * had practiced tai chi within the past 6 months * had exercised \>30 min three times weekly for past 3 months * could not independently ambulate without assistive devices * had bpi pain severity or interference scores less than 5 * had planned elective surgery during study period * were actively involved in health-related litigation * were unwilling to keep all treatments/medications steady throughout the study period
wuhan high myopia study

Conditions: High Myopia

Summary: the study aims to observe the long-term changes of ocular（especially fundus） structure and visual function in patients with high myopia, so as to provide evidence for the prevention, diagnosis and prognosis of high myopia.

high myopia is defined as a refractive error of ≤-6.00d or an axial length greater than 26mm. in recent years, the population of highly myopic individuals has been increasing rapidly. scholars predict that if no effective interventions are taken, the global incidence rate of myopia is expected to increase from 22.9% in 2000 to 49.8% in 2050, and the visual impairment caused by high myopia will be seven times higher than in 2000 on a global scale. in china, a survey conducted by the national health commission in 2018 found that highly myopic students accounted for 21.9% of third-year high school students, indicating that high myopia has become a major public health issue due to its prevalence among younger populations. in recent years, with the development of ocular imaging technologies such as optical coherence tomography (oct) and corresponding image analysis techniques, high-resolution, non-invasive, fast and in vivo retinal imaging has become more accessible. this has led to the discovery and exploration of various imaging parameters related to optic disc and macula changes in highly myopic patients. we will conduct a 4 years prospective cohort study in the population of 1000 high myopia and controls which have established in mainly college student population, using the latest oct-a and ss-oct to observe the long-term changes of fundus structure combined with visual function in patients with high myopia , and explore biomarkers affecting visual function, so as to provide basis for prevention and control of high myopia and prognosis.

Eligibility criteria:
inclusion criteria: * voluntarily sign informed consent; * commit to follow the research procedures and cooperate with the whole process of the study; * age ≥18 years old; * best corrected visual acuity ≥0.1; * spherical equivalent refraction≤-6.00d or axial length ≥26mm in high myopia group； exclusion criteria: * unable or unwilling to sign informed consent; * unable to cooperate with the examination; * astigmatism ≤-1.5d； * patients with refractive interstitial opacity so that fundus images cannot be collected； * patients with fundus diseases such as diabetic retinopathy, hypertensive retinopathy, age-related macular degeneration, retinal vein obstruction, retinal artery obstruction, etc

Keywords: ocular biometric parameters refractive errors
clinical effectiveness of s53p4 bioactive glass in treatment of long-bone chronic osteomyelitis

Conditions: Osteomyelitis; Bone Infection; Non-Union Fracture; Bone Infection of Lower Leg; Bone Infection of Pelvis, Hip, or Femur

Summary: this clinical trial studies the clinical effectiveness of s53p4 bioactive glass (bag) as a bacterial growth inhibiting bone graft substitute in a one-stage or two-stage surgical procedure for treatment of chronic long bone osteomyelitis.

in this prospective multicenter study, patients from two different university hospitals in the netherlands were included. treatment consisted of debridement surgery, implantation of s53p4-bag, if necessary wound closure by a plastic surgeon and additional culture based systemic antibiotics. primary outcome was eradication of infection based on clinical presentation, radiographic imaging and laboratory tests. secondary analysis was performed on probable risk factors for treatment failure after s53p4-bag implantation.

Eligibility criteria:
inclusion criteria: * patients with a clinical, radiographic and/or laboratory study confirmed chronic osteomyelitis of long bones * patients who are physically and mentally willing and able to comply with postoperative functional evaluation. * patients that can read and understand the dutch language. exclusion criteria: * patients with an diabetic ulcer related chronic osteomyelitis * patients that are pregnant. * patients who are unwilling to cooperate with the study protocol and follow-up schedule. * patients who, as judged by the surgeon, are mentally incompetent or are likely to be non-compliant with the prescribed post-operative routine and follow-up evaluation schedule. * patients with malignancy - active malignancy within last 1 year * patients known with a diagnosed systemic disease that would affect the subject's welfare or overall outcome of the study (severe osteoporosis requiring medication, paget's disease, renal osteodystrophy,hypercalcemia ) or is immunologically suppressed, or receiving steroids in excess of physiologic dose. * patients with a neuromuscular or neurosensory deficit which would limit the ability to assess the performance of the device or the patient has a neurological deficit which interferes with the patient's ability to limit weight bearing or places an extreme load on the implant during the healing period. * patients with systemic or metabolic disorders leading to progressive bone deterioration * patients with other concurrent illnesses that are likely to affect their outcome such as all autoimmune diseases (including ra), sickle cell anaemia, systemic lupus erythematosus, psoriasis, not controlled type 1/2 diabetes or renal disease requiring dialysis. * patients with a known sensitivity to device materials * patients that are an alcohol and/or drug abuser as defined by currently undergoing treatment for alcohol and/or drug abuse

Keywords: bioactive glass s53p4 bag bonalive chronic osteomyelitis
epidemiology and prevention of anxiety and depression in parents of hospitalized neonates

Conditions: Depression

Summary: the overall goal of this project is to elucidate the epidemiology of anxiety and depression in parents of hospitalized neonates and test a comprehensive intervention program to prevent anxiety and depression in parents in this setting.

parents of hospitalized neonates experience high stress levels and feelings of helplessness in the neonatal ward and often concern for the health and well being of their fragile infant. parental stress associated with admission to the neonatal ward of infants has been extensively studied in developed countries for many years, but rarely have epidemiological and intervention studies been reported in chinese parents of hospitalized neonates. the aim of the present study was to elucidate the epidemiology of anxiety and depression in parents of hospitalized neonates and test a comprehensive intervention program to prevent anxiety and depression in parents in a chinese hospital.

Eligibility criteria:
inclusion criteria: * speaks and reads chinese * no severe handicapping conditions or mental diseases * informed consent, no medical dispute * infants born within 28 days to be cared in the neonatal ward for at least 24 hours exclusion criteria: * significant mental health history * newborns died within a week after hospitalization

Keywords: neonates parenting anxiety depression
brown adipose tissue and body mass index

Conditions: Obesity; Type 2 Diabetes Mellitus

Summary: in this study the investigators aim to investigate whether the sympathetic stimulation of bat, as assessed with a 123i-metaiodobenzylguanidine single-photon emission computed tomography computed tomography scan, differs between lean and obese individuals, as an explanation for the diminished metabolic brown adipose tissue activity in obese subjects. the investigators hypothesis is that sympathetic nervous system activity in the obese is diminished as compared to their leaner counterparts as an explanation for the diminished metabolic brown adipose tissue activity in the obese.

the sympathetic nervous system is the primary activator of brown adipose tissue. obese humans are known to have less metabolically active brown adipose tissue as compared to their leaner counterparts. the reason for this diminished metabolic brown adipose tissue activity is unknown. however, a lower sympathetic nervous system activation to brown adipose tissue in the obese might explain a diminished metabolic brown adipose tissue. therefore, in this study, both the sympathetic nervous system activation to brown adipose tissue and the metabolic activity will be measured in lean and obese subjects. sympathetic nervous system activity will be measured using 123i-metaiodobenzylguanidine single-photon emission computed tomography scans, metabolic activity will be measured using 18f- fluorodeoxyglucose positron emission tomography ct scans.

Eligibility criteria:
inclusion criteria: * male * caucasian origin * subjects should be able and willing to give informed consent * 18-40 years old * bmi range of 19-25 kg/m2 (lean study subjects) or 28-40 kg/m2 (obese study subjects) exclusion criteria: * renal failure (creatinine\>135mmol/l) * daily use of prescription medication

Keywords: brown adipose tissue weight sympathetic nervous system